FDA Adverse Event
Other
Summary report: N
THINPREP IMAGING SYSTEM
MDR report key: 1221809
·
Received November 4, 2008
Report
- Report Number
- 1222780-2008-00116
- Event Type
- Other
- Date Received
- November 4, 2008
- Date of Event
- October 7, 2008
- Report Date
- November 4, 2008
- Manufacturer
- HOLOGIC INC.
- Product Code
- MNM
- PMA / PMN Number
- P020002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PATIENT SLIDE WAS REVIEWED AT THE CYTOLOGY LAB ON A REVIEW SCOPE AND OTHER MICROSCOPES.
Description of Event or Problem · 1
POSSIBLE FALSE NEGATIVE. CASE PRESENTED HAD NO TRIGGERS IN THE 22 FIELDS OF VIEW (FOVS) TO PROMPT AN AUTOSCAN. WHILE SCANNING THE SLIDE FOR ENDOCERVICAL COMPONENT (NOT ON THE REVIEW SCOPE) SLIDE SHOWED A LARGE CLUSTER OF LSIL CELLS NOT IN THE 22 FOVS. SITE WILL BE MONITORED TO DETERMINE IF EXPECTED OCCURENCES (AS DETERMINED BY THE (B) (6) STUDY) ARE EXCEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THINPREP IMAGING SYSTEM | AUTOMATED MICROSCOPE FOR CYTOLOGY | MNM | HOLOGIC INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |